Alcon Patanase chemistry issues
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Alcon is testing a modified formulation of its pending olopatadine nasal spray Patanase after receiving "correspondence from…FDA requiring that the current formulation of the drug be modified to reduce or remove one of the inactive ingredients it contains before Patanase nasal spray can be approved," Alcon says Nov. 7. The company previously had indicated it expected such a request. The Patanase NDA for seasonal allergic rhinitis was submitted in December 2004; Patanase contains the same active ingredient as the firm's allergic conjunctivitis treatment Patanol...